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Gage / Measurement Uncertainty - QS-9000 QSR 3rd Edition 4.11.1


Theron Taylor

Has anyone been audited to QSR 3rd Edition and gotten a reading on Gage R&R activities as satisfying the Gage Uncertainity requirement in QSR 4.11.1? Also I would like to have conversation with one or more persons who has experienced the 3rd Edition Lab audit. I have a product qualification/test lab in addition to metrology lab activities. We are a tier one parts supplier.

Bryon C Simmons


Been through the 4.10.6 thing. My company makes industrial packaging...primarily returnables for the car people. Basically, I used the guidelines for Lab scope that are included in the Glossary of the Third Edition. There, under the definition of Lab scope, it lays out all the requirements that need to be included in the scope. Basically, I created a Level II document, and included all of the necessary information. This includes all standatds, etc. that you are testing to..i.e. ASTM, ASME, Also, you will need to have copies of all referenced standards on site.

This includes any calibrations that you may be doing in house. If you are, you must list any calibration "masters" that you are using...i.e. gage block sets, etc.

Hope this helps


Theron Taylor

Thanks for the reply Bryon,

We will have a surveillance audit 8, 9th, and 10th of March. This will be to 3rd Edition of course. I had read your earlier posting about 3rd Edition. You mentioned a couple of things I had overlooked. I did similar to you, in that I wrote a Level ll document that described the scope of our lab activities. I still have a question about the uncertainity requirements. Does GR & R satisfy 4.11.1? Can general purpose standard gages like mikes be treated as a class of gage by doing GR & R one time for the class? What were your auditors comments concerning the confidentially clause?
Am I OK to assume you can do a Gage R & R on a mic, calculate 6 sigma form the measurements, and develop an uncertainty from that?
Sorry to answer your question with a totally different question here. My apologies. I am uncertain about uncertainty.

Theron Taylor

Hi Dawn,
I am not of much help in this area, thus the reason for my questions? Maybe Marc or someone else has some input on this subject. The MSA Reference Manual leads you through the subject, but I am unclear as to what auditors are accepting in the real world. I have about 4000 peices of production mechanical gage items and 800 peices in my electrical metrology system. Resources for doing excessive gage studies are impossible to get.

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